MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-10 for RHOTON SHARP MICRO NERVE HOOK FW-4700 manufactured by Fischer Surgical, Inc..
[89374709]
While performing surgery, piece of rhoton sharp micro nerve hook broke off in pt. Unable to locate prior to end of case and closure of wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072654 |
| MDR Report Key | 6935624 |
| Date Received | 2017-10-10 |
| Date of Report | 2017-10-05 |
| Date of Event | 2017-08-14 |
| Date Added to Maude | 2017-10-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RHOTON SHARP MICRO NERVE HOOK |
| Generic Name | NERVE HOOK |
| Product Code | GDG |
| Date Received | 2017-10-10 |
| Model Number | FW-4700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISCHER SURGICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-10 |